As the FDA finally cracks down on kratom, decades of de-regulation have flooded shelves with questionable supplements and off-brand opioids.
On the shelf of your local gas station, somewhere between the lottery tickets and the gummy worms, sits a cobalt-blue bottle advertising “mood lift, energy, focus.” This potion looks like something out of Alice in Wonderland, but you’ll only need to travel as far as your closest 7-11 to find it—and for the low price of $7.95 a bottle, it promises to make you feel free. Across the country, however, thousands of Americans are struggling to break from its grip. Created from a mixture of leaf kratom and kava, Feel Free tonics taste like pineapple juice and are marketed as “plant-based herbal supplements.” Their main ingredient, kratom, is found in the leaves of a Southeast Asian tree; users report that it acts like a stimulant in low doses and a sedative at higher ones. While some trace its U.S. arrival to soldiers returning from Vietnam, kratom really gained traction in the mid-2000s as an at-home remedy for opioid withdrawal. Kava, meanwhile, is harvested from the root of a South Pacific pepper shrub and is often used to treat anxiety. Combine these two tropical herbs and you’ve got an all-natural, stress-free cocktail—or possibly a nightmare. “These drinks are insane and not only leave you financially ruined but also physically and mentally. I am fucked,” reads a recent post on the r/QuittingFeelFree Reddit group. The user says they started out drinking one tonic a week, then two a day, until they were eventually finishing entire cases—twelve bottles worth—daily. (It should be noted that Feel Free recommends that consumers drink no more than one bottle per day.) After purchasing what they told themselves would be their final two tonics, the Reddit user writes, they experienced an incident that can only be described as rock bottom. Sitting in their car, they say they lost all bodily function, vomiting, defecating and urinating on themselves as their vision blurred: “[Passersby] called the paramedics and when they came I tried to get out of my car and fell backwards on the ground. Still throwing up, still pissing myself. I had no bodily control.” Sure, this person admits to exceeding the daily dosage of the tonic by tenfold. But the real question is how people are reaching that level of addiction in the first place, and why tens of thousands of Americans are hooked on so-called natural “supplements.” The Food and Drug Administration has recently taken steps to ban the concentrated active ingredient found in many kratom products, known as 7-Hydroxymitragynine or 7-OH—but the move comes far too little too late (and in any case, the ban wouldn’t affect tonics like Feel Free, which use “natural leaf kratom”). The story of how this stuff is even legal in the first place is a classically American one. It involves decades of lobbying, an innately broken healthcare system, and one particularly crooked senator from Utah, whose lasting legacy includes amplifying the opioid crisis while ensuring that off-brand narcotics and unregulated boner pills stay on the shelves. Back in 1994, Americans would be forgiven if the passage of a dietary supplement act wasn’t top of mind. Kurt Cobain died (so did Richard Nixon), apartheid ended in South Africa, and thousands of people sat glued to the TV as the former running-back for the Bills led police across Los Angeles in his white Ford Bronco. There was a lot going on. Meanwhile, a Utah Republican by the name of Orrin Hatch was devising a plan to unravel the FDA’s regulatory powers. Hatch was a tried-and-true Book-of-Mormon-touting conservative, and his belief in limited government led him to draft the Dietary Supplement Health and Education Act: a bill that would exempt the supplement industry from nearly all federal regulation. The act was advertised as a common-sense safeguard against government meddling. One memorable commercial featured the actor Mel Gibson getting raided by a team of armed FDA agents; when an officer points a gun at him and yells “FREEZE!", Gibson puts his arms in the air to reveal an open bottle of Vitamin C tablets. What the law actually accomplished was the total annihilation of consumer protections. After it passed Bill Clinton’s desk in October 1994, the FDA no longer had any power to block a supplement from reaching the market; the agency could only prove a product’s danger after it was already in stores. The burden of proof now fell on the government, not the manufacturers. Under the new law, companies were allowed to make unproven claims about their products, just as long as this fine print followed: this statement has not been evaluated by the Food and Drug Administration. They couldn’t explicitly claim to treat, cure, or prevent any disease (that would require actual clinical trials!), but they could come pretty damn close. Today, this clause is why the pyramid scheme Herbalife can market lemon-flavored powders that “support vascular health” but not treat hypertension. It’s why Feel Free tonics say they’ll make you “feel good,” not cure your depression. For desperate consumers, however, this distinction is little more than a legal loophole. When real prescriptions cost hundreds, why not reach over the counter for a little off-brand relief? Unsurprisingly, Hatch had a few key industry backers. The LA Times writes: It wasn’t the desire for “rational regulation,” but that most common political drug of all, money. The dietary supplement industry had set up shop in Hatch’s home state and plied him with pantsfuls of campaign cash; in 2010, for instance, Utah-based Xango LLC, which markets dietary supplements among other products, was Hatch’s second-biggest contributor. (Herbalife ranked third.) Hatch’s son, Scott, has worked as a lobbyist for the industry. Thanks to DSHEA, the supplements industry grew from $9 billion in 1994 to more than $50 billion today. In Utah alone, it’s worth more than $7 billion. Indeed, Hatch’s landslide victory against the FDA proved rather fruitful for his friends and family. Two decades after the act’s passage, the New York Times noted that it’s nearly impossible to drive along Utah’s interstate without spotting the stains from Hatch’s 1994 snake-oil spill: In the town of Lehi is the sprawling headquarters of Xango, where company officials praised Mr. Hatch, a Utah Republican, late last year for helping their exotic fruit juice business “operate without excessive intrusion” from Washington.[…] And nearby in West Salem, assembly-line workers at Neways fill thousands of bottles a day for a product line that includes Youthinol, a steroid-based hormone that professional sports leagues pushed to ban until Mr. Hatch blocked them. […] Mr. Hatch’s grandson and son-in-law increase revenue at their chiropractic clinic near here by selling herbal and nutritional treatments, including $35 “thyroid dysfunction” injections and a weight-loss product, “Slim and Sassy Metabolic Blend.” Eventually, politicians began to suspect that the unregulated shilling of “health products” wasn’t a great idea. In 2010, Senator John McCain proposed a new law that would increase the FDA’s power to review nutritional supplements before they hit shelves, citing multiple cases in which professional athletes had failed drug tests after taking shady products. (One such incident occurred in 2001, when Olympic bobsledder Pavle Jovanovic claimed that his positive steroid screen was caused by a spiked supplement. Although sport officials supported his story—and later analysis showed that a damning 18 percent of supplements contain undeclared steroids—Jovanovic was still barred from the upcoming Games, coincidentally held that year in Salt Lake City, Utah.) Shortly after introducing the legislation, however, Senator McCain’s backbone dissolved faster than a spoonful of protein powder. The senator mysteriously abandoned his own bill after meeting with Hatch, who thanks him for his spinelessness in this signed letter: “I’m counting on you working with me to make sure this important industry does not fall prey to over-regulatory regimes and mounds of costly government bureaucracy[…] In short, we will ensure safe supplements are always available to consumers and the dietary supplement industry will continue to innovate and grow.” Hatch’s contributions to America’s drug crisis didn’t end with the vitamin aisle. In 2016, just as the United States was reaching a record-high peak of opioid deaths, Congress decided to cozy up with the nation’s major drug distributors. According to a joint investigation by 60 Minutes and the Washington Post, the passage of the Ensuring Patient Access and Effective Drug Enforcement Act provided new legal pathways for opioids and other narcotics to flow into the streets: For years, some drug distributors were fined for repeatedly ignoring warnings from the DEA to shut down suspicious sales of hundreds of millions of pills, while they racked up billions of dollars in sales. The new law makes it virtually impossible for the DEA to freeze suspicious narcotic shipments from the companies, according to internal agency and Justice Department documents and an independent assessment by the DEA’s chief administrative law judge in a soon-to-be-published law review article. (…) The law was the crowning achievement of a multifaceted campaign by the drug industry to weaken aggressive DEA enforcement efforts against drug distribution companies that were supplying corrupt doctors and pharmacists who peddled narcotics to the black market. The industry worked behind the scenes with lobbyists and key members of Congress, pouring more than a million dollars into their election campaigns. The bill was passed after Senator Hatch negotiated a final version with the DEA. He received over $2.5 million in donations from the pharmaceuticals/health industry from 1989 to 2016, according to filings from the Federal Trade Commission, and received $177,000 from the drug industry alone while pushing the bill through. (After 60 Minutes and the Washington Postpublished their investigation, Hatch responded with his own op-ed telling them to “leave the conspiracy theories to Netflix.”) Both of these bills helped create the conditions for today’s "herbal" addiction economy, with many people now turning to kratom tonics in a desperate bid to taper off the opioids they became hooked on in the wake of this deregulated flood. First, the pills were too easy to get, then suddenly they were impossible to quit. Into that void rushed the wellness industry, offering a thousand natural band-aids for a crisis it helped create. Gas stations and head shops across the country now stock a smorgasbord of unregulated or barely-regulated substances marketed as “supplements,” each promising to soothe, arouse, or otherwise optimize the chemically depleted consumer. There’s tianeptine, a tricyclic antidepressant sold under names like ZaZa or Tianaa, which users call “gas station heroin” for its opioid-like effects and vicious withdrawals. There's phenibut, an anti-anxiety drug developed in the 1960s Soviet Union for military personnel, which is still legal in the U.S. and sold under euphemisms like “mood support” or “nootropic focus” (despite reports of hallucinations and benzo-like withdrawal in regular users). And then, of course, there are the legendary Rhino pills: a phallic family of nightmare ingredients sold as “all-natural male enhancement.” These are often found to contain unlisted compounds like sildenafil and tadalafil, the active ingredients in Viagra and Cialis, which can lower blood pressure to dangerous levels. The FDA hasissueddozens of warnings about these products, but their packaging just gets shinier and their names more ridiculous (Rhino 69 Power 35000! TIME. SIZE. STAMINA). In any other context, selling misbranded pharmaceuticals with undeclared ingredients might result in criminal charges. But under the legal umbrella of “supplements,” these products operate in a regulatory twilight zone. The FDA doesn’t test them before they hit the market, and unless someone dies (or worse, gets on the news) no one steps in to stop them. The agency’s proposed ban on 7-Hydroxymitragynine may be a good step, but it’s not even close to solving the real problem. Even if 7-OH disappears from the market tomorrow, the same loopholes that allowed kratom products to be sold as harmless “mood boosters” to begin with are still wide open. People didn’t get addicted to Feel Free because of a banned compound; they got addicted because our leaders allowed these products to be marketed as wellness tonics in the first place. We allowed companies to sidestep the standards applied to every other mind-altering drug in the country because they slapped a “natural” label on the bottle. And now that thousands of people are hooked, the response from regulators is to play ingredient whack-a-mole rather than ask why these products were allowed to flood the shelves to begin with. When I posted on Reddit asking to speak to users about their experiences with Feel Free, I received an email within minutes from a PR representative for Botanic Tonics, the company that produces it. The rep firmly explained (in bold text!) that Feel Free should not be conflated with products containing 7-OH: “There is a distinct difference between the natural leaf kratom we use in Feel Free and 7-OH products,” they wrote. “We support the FDA announcement.” The rep touted the company’s voluntary labeling improvements and commitment to education, and emphasized that they manufacture everything in a cGMP-certified facility (meaning in compliance with the FDA’s Current Good Manufacturing Practices). Of course, Botanic Tonics didn’t mention what likely led them to make “voluntary” improvements: In 2023, the company settled an $8.75 million class-action lawsuit with consumers who said Feel Free was misleadingly advertised as a safe alternative to alcohol. Prior to the lawsuit, company founder J.W. Ross (himself a recovering alcoholic) described the tonic as a “social lubricant”—a way to unwind without the hangovers and negative side effects of drinking. Their packaging now includes a disclaimer that the product may be habit-forming “like caffeine and alcohol.” And sure, this specific company does use a less-concentrated form of kratom than others. But that doesn’t answer the question haunting every user on r/QuittingFeelingFree: If the product is so safe, why can’t I stop drinking it? While researching this article, I took a cross-city tour of New Orleans’ many smoke shops in search of that all-natural plant-based supplement. My journey was ultimately fruitless: I’d forgotten that a few days prior, a new law had gone into effect in Louisiana, making it the first state to ban kratom entirely—no matter its concentration. The supplement is now classified as a Schedule 1 controlled substance, the same category as heroin. While the wooden signs flanking French Quarter vape shops still promise “KRATOM INSIDE,” their shelves are now empty. “You looking for Feel Free?” asked one man behind the counter of a corner store. “That stuff’s fucked, man. We sold it, but I always told people not to do it…they say it’s dangerous now, after everyone’s already addicted?” The cashier told me that one regular customer used to stop by four times a day, buying a double-pack of tonics each visit. I wondered what new substance he may have taken to now, hoping to stave off withdrawals. The truth is, you don’t need 7-OH to ruin someone’s life. You just need a broken regulatory system and a market full of overworked and underinsured people looking for something to take the edge off. That’s what makes the FDA’s ban feel so hollow. It’s not that banning 7-OH is wrong; it’s that the entire architecture of supplement regulation operates on backwards thinking. Companies can profit from selling psychoactive drugs without proving they’re safe, while consumers are left to sort through Reddit forums and emergency room visits all on their own. Treating consumption as a crime won’t fix the issue either. Like my new friend at the corner store so astutely pointed out, our government allowed these products on the shelves—and will soon throw people in jail for possessing a substance they were told would help. We are now decades into this deregulated mess, all thanks to one senator’s paid-for crusade against “costly government bureaucracy.” The FDA can ban a molecule after it’s already ruined thousands of lives, but it’ll take a whole lot more to undo the environment that birthed it. Until that changes, there will always be another tonic, another loophole, and another American passed out in a parking lot, clutching a little blue bottle.